Glial Fibrillary Acidic Protein Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point of Care Testing and Handheld Near Infrared Spectroscopy Technology CEREBO in India.
CEREBO is an ICMR award winning point-of-care (POC) adjunct CT scanning device for detecting brain hematomas in patients with head injury. The study aims to validate the diagnostic accuracy of the PREDICT Assessment Model (CEREBO-NIRS plus GFAP/D-Dimer POC Assay) in patients with suspected stroke. The study will be conducted as part of the Indian Council of Medical Research's National Health Research Priority (ICMR-NHRP) under the INDIA-EMS project using a two phase design.
PHASE I: Validation of a diagnostic accuracy and feasbility of PREDICT assessment model (a combined approach using GFAP/ D-dimer POC lateral flow assay plus CEREBO-NIRS technology).
Study Design: Prospective, Multicenter, Validation and Feasibility Study.
PHASE II: Pilot RCT to assess integration of the PREDICT assessment model into pre-hospital pathways.
Study Design: Pilot Randomized Controlled Trial (RCT) (Year 3-5)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study, titled "Prehospital Rapid Evaluation and Detection in Cerebrovascular Triage: A Multicenter Study of Glial Fibrillary Acidic Protein Point-of-Care Testing and Handheld Near-Infrared Spectroscopy Technology (CEREBO) in India," aims to validate the PREDICT Assessment Model, which combines GFAP/D-Dimer point-of-care testing with handheld CEREBO Near-Infrared Spectroscopy (NIRS) technology for the rapid differentiation of ischemic stroke and intracerebral hemorrhage in the prehospital setting.
The study will be conducted under the Indian Council of Medical Research (ICMR) National Health Research Priority (NHRP) programme as part of the INDIA-EMS project and will use a two-phase design. Phase I is a prospective, multicenter validation and feasibility study involving patients with suspected acute stroke presenting by ambulance or directly to the emergency department. Participants will undergo clinical assessment, including BE-FAST and neurological assessment, finger-prick blood testing for GFAP/D-Dimer, and CEREBO-NIRS assessment. All participants will subsequently undergo standard diagnostic evaluation with a CT head scan, which will serve as the gold standard for stroke subtype classification. The diagnostic accuracy, feasibility, process times, and safety of the combined PREDICT Assessment Model will be evaluated.
Phase II will be a pilot randomized controlled trial evaluating the integration of the PREDICT Assessment Model into prehospital stroke pathways. Ambulance services within the catchment areas of CMC Ludhiana and JIPMER Puducherry will be randomized to intervention or control groups. In the intervention group, ambulance personnel will use GFAP/D-Dimer testing and CEREBO-NIRS technology to support prehospital stroke classification and triage, in coordination with the on-call stroke team. The control group will receive standard care, including transport to the hospital for CT-based diagnosis and subsequent treatment decisions.
The primary objective of the study is to validate the diagnostic accuracy and feasibility of the combined GFAP/D-Dimer and CEREBO-NIRS approach and to assess its potential impact on prehospital stroke triage. Phase II will additionally assess the effect of the intervention on the time from ambulance dispatch to initiation of stroke-specific treatment. Secondary outcomes include functional outcome at 90 days measured by the modified Rankin Scale, in-hospital mortality, and adverse events.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Dr Ivy A Sebastian
- 전화번호: 09592588138
- 이메일: ivy29cmc@gmail.com
연구 연락처 백업
- 이름: Dr Jeyaraj D Pandian, MD DM
- 전화번호: 9915784750
- 이메일: jeyarajpandian@hotmail.com
연구 장소
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Puducherry
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Puducherry, Puducherry, 인도, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry JIPMER
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연락하다:
- Dr Manu Ayyan
- 전화번호: 9846556133
- 이메일: manuayyan@hotmail.com
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Punjab
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Ludhiana, Punjab, 인도, 141008
- Christian Medical College and Hospital
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연락하다:
- Dr Ivy A Sebastian
- 전화번호: 9999464986
- 이메일: ivy29cmc@gmail.com
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Phase 1
Inclusion criteria
- Adult patients of any gender ≥18 years with clinically suspected stroke
- Transported by ambulance or presenting directly to ED of participating hospitals
- Time from symptom onset/ Lost known well time (within 24 hours)
- Consent provided by patient/ next of kin
Exclusion criteria:
- Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ICH in last 3 months, Diagnosis of brain tumour/SOL)
- Patients with known medical condition with estimated life expectancy ≤ 3 months
- Those refusing consent
Phase 2
Inclusion criteria:
- Adult patients of any gender ≥18 years with clinically suspected stroke
- Transported by ambulance to ED of participating hospitals
- Time from symptom onset/ Last well known time (≤ 24 hours)
- NIHSS ≥ 5
- Consent provided by patient/ next of kin
Exclusion criteria:
- Patients with known pre-existing neurological conditions that may confound diagnosis (Concurrent traumatic brain injury, recent TBI in last 3months, IS/ ICH in last 3 months, Diagnosis of brain tumour/ SOL)
- Patients with known medical condition with estimated life expectancy ≤ 3 months
- Those refusing consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: PREDICT Assessment Model
Ambulances in the intervention group will use the GFAP/D-Dimer point-of-care test and CEREBO Near-Infrared Spectroscopy (NIRS) technology to classify suspected acute stroke in the prehospital setting. Patients suspected of ischemic stroke and large vessel occlusion will be rapidly triaged to a comprehensive stroke centre, while patients suspected of intracerebral hemorrhage will receive stringent blood pressure control in the ambulance according to established protocols. Decision-making will be undertaken in conjunction with the on-call stroke team through the PREDICT App. |
A finger-prick blood sample will be obtained from patients with suspected acute stroke and tested using a GFAP/D-Dimer lateral flow assay. The test will provide rapid biomarker results to support differentiation between ischemic stroke and intracerebral hemorrhage in the prehospital setting and The handheld CEREBO-NIRS device will be applied non-invasively to the patient's scalp to detect intracranial hematoma by assessing asymmetry in near-infrared optical density. The findings will be recorded and used as part of the PREDICT Assessment Model for stroke subtype classification. |
|
활성 비교기: Standard Care
Ambulances in the control group will follow standard care procedures, including rapid transport of patients to the hospital for CT head imaging, followed by treatment decisions based on the CT findings. |
Standard care CT head imaging |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PREDICT assessment model
기간: 30 mins
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(Phase 1) Sensitivity and Specificity and PREDICT assessment model. Accurate identification of ICH >90% using PREDICT model. |
30 mins
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Time for Device Application by Paramedics
기간: 30 mins
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(Phase 1) The time taken by paramedics/ ED personnel to apply the CEREBO NIRS device and obtain GFAP/D Dimer results. Lesser time indicates good outcome. |
30 mins
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Treatment initiation
기간: 30 mins
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(Phase 2) Time from Ambulance dispatch to initiation of stroke-specific treatment (Triage to Stroke ready centre or rapid BP control). Lesser time indicates better outcome. |
30 mins
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Inter-Center Variability
기간: 2 years
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(Phase 1) Comparison of diagnostic accuracy and feasibility metrics between CMC Ludhiana and JIPMER Puducherry to assess consistency across centres. More consistency indicates good outcome. |
2 years
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Correlation with Gold Standard
기간: 2 years
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(Phase 1) Agreement between the PREDICT assessment model and the CT head scan diagnosis (the gold standard). More correlation indicates better outcome. |
2 years
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Safety Metrics
기간: 2 years
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Phase 1 Documentation of adverse events related to the testing procedure. Fewer events indicate a better outcome. |
2 years
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modified Rankin Scale
기간: 90 days
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Phase 2 Functional outcome at 90 days Lower score (0-3) indicates good outcome |
90 days
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In-hospital mortality
기간: 7 days
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Phase 2 In-hospital mortality. Lesser mortality indicates better outcome |
7 days
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Adverse events
기간: 90 days
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Phase 2 Incidence of adverse events (e.g., symptomatic ICH). Lesser events indicate better outcome. |
90 days
|
공동 작업자 및 조사자
스폰서
스폰서
협력자
협력자
수사관
수사관
- 수석 연구원: Dr Ivy A Sebastian, Christian Medical College and Hospital, Ludhiana, India
- 수석 연구원: Dr Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, India
간행물 및 유용한 링크
일반 간행물
- Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.
- Kalra LP, Khatter H, Ramanathan S, Sapehia S, Devi K, Kaliyaperumal A, Bal D, Sebastian I, Kakarla R, Singhania A, Rathore S, Klinsing S, Pandian JD, Foerch C. Serum GFAP for stroke diagnosis in regions with limited access to brain imaging (BE FAST India). Eur Stroke J. 2021 Jun;6(2):176-184. doi: 10.1177/23969873211010069. Epub 2021 May 11.
- Berkowitz AL. Managing acute stroke in low-resource settings. Bull World Health Organ. 2016 Jul 1;94(7):554-6. doi: 10.2471/BLT.15.162610. Epub 2016 Jun 2. No abstract available.
- Abraham SV, Joy A, Sahu AK, Ravindra P, Dhar S, Teja R, Krishnan SV, Liu R, Rudd AG, Ford GA. Barriers to Effective Prehospital and Hyperacute Stroke Care in India: A Physician Perspective. J Emerg Trauma Shock. 2024 Jul-Sep;17(3):129-135. doi: 10.4103/jets.jets_156_23. Epub 2024 Aug 30.
- Palaniswami M, Yan B. Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice. Interv Neurol. 2015 Oct;4(1-2):18-29. doi: 10.1159/000438774. Epub 2015 Sep 18.
- Ren C, Kobeissy F, Alawieh A, Li N, Li N, Zibara K, Zoltewicz S, Guingab-Cagmat J, Larner SF, Ding Y, Hayes RL, Ji X, Mondello S. Assessment of Serum UCH-L1 and GFAP in Acute Stroke Patients. Sci Rep. 2016 Apr 14;6:24588. doi: 10.1038/srep24588.
- Ramos-Pachon A, Lopez-Cancio E, Bustamante A, Perez de la Ossa N, Millan M, Hernandez-Perez M, Garcia-Berrocoso T, Cardona P, Rubiera M, Serena J, Ustrell X, Garces M, Terceno M, Davalos A, Montaner J. D-Dimer as Predictor of Large Vessel Occlusion in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):852-858. doi: 10.1161/STROKEAHA.120.031657. Epub 2021 Feb 10.
- Gaude E, Murphy D, Gerstl JVE, Kappel AD, Dmytriw AA, Nawabi NLA, Izzy S, Guardia REA, Vicenty-Padilla JC, Gropen T, Patel NJ, Liebeskind DS, Siddiqui AH, See AP, Aziz-Sultan MA, Bernstock JD. Detection of GFAP and D-Dimer in a Point-of-Care Test for Large Vessel Occlusion Ischemic Stroke. Stroke Vasc Interv Neurol. 2025 Jan 11;5(2):e001559. doi: 10.1161/SVIN.124.001559. eCollection 2025 Mar.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PREDICT INDIA-EMS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The study protocol does not currently specify a plan for sharing individual participant data (IPD) with other researchers. Any future IPD sharing will be considered in accordance with applicable ethical, regulatory, and data-protection requirements.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .